JP2022522118A - Combined electrosurgery and mechanical excision device - Google Patents

Abstract

A complex medical device for removing and treating a patient's tissue is disclosed. The device includes a reusable handle and a blade that can be selectively connected to the handle. The blade comprises an outer sleeve having a lumen including an inner shaft disposed internally. The inner shaft may be coupled to a motor drive unit disposed within the handle and may rotate to mechanically cut tissue as the inner shaft rotates. The outer sleeve contains at least one electrode for electrosurgical treatment of the tissue. The reusable handle includes at least one control switch for controlling the parameters associated with the rotation of the inner shaft. The blade may also include a switch assembly that telecommunications with at least one electrode, which includes mounting means for selective mounting of the switch assembly on a reusable handle.
[Selection diagram] Fig. 1

Description

The present disclosure relates to surgical instruments and related methods for excision and electrosurgical treatment of tissue in general. The present disclosure is more specifically used in arthroscopic surgery, including an electric handheld instrument coupled to a mechanical excision blade integrated with multiple electrodes for ablation, cutting, or coagulation of tissue. Regarding the system for.

Surgical tools designed for mechanical cutting of tissue have been used for many years. These types of tools typically include an electric handpiece and a rotary cutting blade anchored to the distal end of the handpiece. The blades are an inner drive member, including a hub that is driveably engaged with the output shaft associated with the motor of the handpiece, and a hub-fixed drive shaft that defines the head at the cutting instrument or its distal end. And may have. An outer cannula-like housing element is disposed around the drive shaft of the inner drive member, defining a cutting window on it, which moves to manipulate the target patient tissue located adjacent to the window. Work with the cutting head.

Electrosurgical tools have also been available for many years and have used electrical energy to treat target patient tissue in a variety of ways. For example, electrocautery is used to seal and close blood vessels during surgery to prevent blood loss. In addition, cauterization can be utilized to vaporize or remove tissue using electrical energy. Electrosurgical probes are typically designed to perform both of these functions, depending on the level of power delivered to them. In addition, unipolar and bipolar electrosurgery tools are conventional, unipolar tools direct current from the active electrode defined on the tool through the patient's body to the return electrode, and the return electrode is typically Is defined by a ground pad attached to the patient. Bipolar tools, on the other hand, include both active and return electrodes, and current is directed between the active and return electrodes through the contacted tissue. More recent developments in electrosurgery use therapeutic devices that use Coblation® technology developed by the assignee of the invention. Coblation® technology involves the application of high frequency voltage differences between one or more active electrodes and one or more return electrodes in order to develop high field strength in the vicinity of the target tissue. High field strength can be generated by applying a high frequency voltage sufficient to vaporize the conductive fluid over at least a portion of the active electrode in the region between the tip of the active electrode and the target tissue. When sufficient energy is supplied to the vaporized conductive fluid, the tissue can be volumetrically removed by molecular dissociation. A more detailed explanation of this phenomenon can be found in US Pat. Nos. 5,697,882, 6,355,032, 6,149,120 and 6,296,136 by the same assignee. It can be found and the entire disclosure thereof is incorporated herein by reference. More recently, the assignees of the invention have further methods of controlling the plasma field by adjusting the volumetric flow rate of suction adjacent to the active electrode in response to the desired tissue effect and in response to the sensed parameters. developed. This may improve the control of energy in the plasma and allow for more targeted tissue effects, for example for a particular tissue type or procedure. A more detailed explanation of this phenomenon can be found at least in U.S. Pat. Nos. 8,192,424, 9,333,024, and 9,713,489 by the same assignee, and their disclosures. The whole is incorporated herein by reference.

In arthroscopic or endoscopic surgery, both mechanical and electrosurgical tools are frequently replaced within a single cannula, discussing the need to combine both options into a single device. This may reduce surgery time and complications associated with bleeding. Composite devices generally tend to come with compromises. First, the added functionality may require an increase in tip diameter or tip geometry, requiring larger and undesired cannulation in the world of endoscopy and arthroscopy. Larger cannula sizes can also prevent access to the required tissue. Alternatively, the mechanically cut surface allows space for additional functionality, but can be recessed or reduced in size at the cost of potentially reduced excision rates. In addition, the option of molecular dissociation of tissue as described above requires the specific plasma resistant material used and involves additional complexity when integrated into a mechanical excision device.

Notations and Terms Specific terms are used throughout the description and claims below to refer to specific system components. As one of ordinary skill in the art will understand, a company that designs and manufactures electrosurgical systems can refer to components by different names. This document is not intended to distinguish between components that differ in name but not in function.

In the following discussion and claims, the terms "include" and "provide" are used in an open-ended format and should therefore be construed as "include, but not limited to". Also, the term "join" is intended to mean either an indirect or direct connection. Thus, when the first device is coupled to the second device, the connection may be via a direct connection or through an indirect connection through another device and connection.

References to singular items include the possibility that multiple identical items may exist. More specifically, as used herein and in the appended claims, the singular forms "a", "an", "said" and "the" are not explicitly indicated by the context. As long as it includes the plural. Further note that the claims may be drafted to exclude any optional element. Accordingly, the present specification is intended to use such exclusive terms as "alone", "only", etc. in connection with the enumeration of elements in the claims, or the limited use of "negative". Serves as a leading foundation. Finally, unless otherwise defined, all technical and scientific terms used herein may have the same meanings as commonly understood by one of ordinary skill in the art to which the invention belongs. Should be understood.

"Cauterization" shall mean removal of tissue based on tissue interaction with plasma.

"Cauterization mode" shall refer to one or more characteristics of cauterization. The lack of cauterization (ie, the lack of plasma) shall not be considered a "cautery mode". A mode in which only coagulation is performed shall not be considered a cautery mode.

By "active electrode" is meant the electrode of the disclosed embodiment that produces an electrically induced tissue-altering effect when in contact with or in close proximity to the therapeutic target tissue.

The "return electrode" serves to provide a current path of charge to the active electrode, the electrode of the disclosed embodiment, and / or itself, an electrically induced tissue change effect on the therapeutic target tissue. It shall mean the electrode of the disclosed embodiment which does not cause the above.

"Controlling the flow of fluid" shall mean controlling the volumetric flow rate. Controlling the pressure applied to maintain a set point pressure (eg, suction pressure) independent of the volumetric flow rate of the liquid caused by the applied pressure is "controlling the flow of fluid". It shall not be considered. However, changing the pressure applied to maintain the set point volume flow rate of the liquid shall be considered to be "controlling the flow of the fluid".

Where a range of values is provided, all intervening values between the upper and lower bounds of the range, and any other description or intervening values within that range, are included within the invention. Is understood. Also, any optional feature of the modifications of the described invention may be described independently or in combination with any one or more of the features described herein and claimed. It is intended.

All existing subject matter described herein (eg, publications, patents, patent applications, and hardware) shall be used unless the subject matter may be inconsistent with the subject matter of the invention (in which case, the book. Anything present in the specification takes precedence), which is incorporated herein by reference in its entirety. The referenced items are provided solely for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as recognizing that the present invention has no prior right to such material by prior invention.

A detailed description of the exemplary embodiment will then be referred to in the accompanying drawings.

FIG. 1 schematically illustrates a system according to the present disclosure that includes a combined surgical device and related equipment connected to a surgical device. FIG. 2 schematically shows the blade portion of a combined surgical device according to the present disclosure. FIG. 3A is an isometric view of the distal blade of a composite surgical device according to the present disclosure. FIG. 3B is a side view of the distal portion of the blade according to the present disclosure. FIG. 3C is a vertical cross section of the distal tip of the blade according to the present disclosure. FIG. 3D is a longitudinal cross section of the distal tip of the blade according to the present disclosure. 4A and 4B are exploded views of the top and bottom of the distal tip of the blade according to the present disclosure. 4A and 4B are exploded views of the top and bottom of the distal tip of the blade according to the present disclosure. 5A, 5B and 5C show a plurality of views of an alternative embodiment of the distal tip of the blade according to the present disclosure. 5A, 5B and 5C show a plurality of views of an alternative embodiment of the distal tip of the blade according to the present disclosure. 5A, 5B and 5C show a plurality of views of an alternative embodiment of the distal tip of the blade according to the present disclosure. 6A and 6B show two different views of the alternative embodiment of the distal blade tip according to the present disclosure. 6A and 6B show two different views of the alternative embodiment of the distal blade tip according to the present disclosure. 7A, 7B and 7C show a plurality of alternative embodiments of the distal tip of the blade according to the present disclosure. 7A, 7B and 7C show a plurality of alternative embodiments of the distal tip of the blade according to the present disclosure. 7A, 7B and 7C show a plurality of alternative embodiments of the distal tip of the blade according to the present disclosure. FIG. 8 shows an alternative embodiment of the distal tip of the blade according to the present disclosure. 9A and 9B show embodiments of a combined surgical device with a disposable switch according to the present disclosure. 9A and 9B show embodiments of a combined surgical device with a disposable switch according to the present disclosure.

In general, the present disclosure describes a system that includes both composite devices that mechanically excise tissue and electrosurgery tissue. Therefore, various embodiments cover different systems and methods for removing tissue using mechanical cutting, electrosurgical ablation and suction. The present specification then moves on to an exemplary system.

Various embodiments are intended for complex medical devices for removing and treating a patient's tissue, including a handle portion and a blade portion. The handle portion includes a motor that can be selectively coupled to a control box for controlling the motor. The blade portion includes an outer sleeve with a lumen extending through it and an inner shaft along the lumen. The outer sleeve is fixed to the handle portion so as to be a stationary sleeve. The outer sleeve has a window at the distal end and the window has a cutting edge. The inner shaft may also have a cutting edge at its distal end and is coupled to a motor capable of moving the inner shaft and working with the outer sleeve window cutting edge to mechanically cut the tissue. .. The inner shaft can rotate, for example. The outer sleeve comprises at least a partially exposed conductive material defining an exposed conductive portion at the distal end of the outer sleeve. The outer sleeve also includes a lateral opening through the thickness of the outer sleeve wall, which is circumferentially spaced from the window. The dielectric spacer is coupled to the lateral opening and extends through the lateral opening. The dielectric spacer may define a portion of the inner lumen of the outer sleeve. The spacer may have an inner surface that defines a portion of the outer sleeve lumen. The dielectric spacer may be configured to replace a portion of the outer sleeve and provide increased rigidity to the outer sleeve when compared to a later unoperated outer sleeve. The dielectric spacer is configured to nest the active electrode and electrically separate the active electrode from the outer sleeve. This allows the exposed conductive portion to be electrically coupled to the RF generator and act as a return electrode.

In some embodiments, the dielectric spacer may be ceramic, or a plasma curable dielectric material that is minimally degraded by adjacent plasma. The lateral opening may have a peripheral edge having a plurality of retaining elements, such as a corresponding axially spaced retaining element on a dielectric spacer and an axially spaced tooth element to be meshed. The spacer may also have a circumferential overhang that partially wraps around / on the outer surface of the outer sleeve. The inner shaft may have a cavity that forms part of the fluid suction element, thereby removing the tissue that is pulled out through the window while mechanically excising the tissue, while the device electrosurgery the tissue. The fluid and plasma by-products drawn out through the active electrode during treatment are removed. The active electrode may have a suction opening through the active electrode for delivering fluid and necrotic tissue pieces into the inner shaft lumen.

Another embodiment of the device for removing and treating a patient's tissue may include an outer sleeve and a rotatable inner shaft disposed therein. The outer sleeve and inner shaft each have an edge that mechanically cuts the tissue as the inner shaft rotates with respect to the outer sleeve. The outer sleeve contains both an active electrode portion and a return electrode portion and is electrically separated from each other by a ceramic spacer. The ceramic spacer is separated from the outer sleeve edge and therefore does not form part of the mechanically cut edge. The spacer extends from the outer peripheral surface of the outer sleeve toward the luminal surface of the outer sleeve through the opening of the outer sleeve.

This outer sleeve opening may have a perimeter containing a plurality of retaining elements that mesh with complementary retaining elements on the ceramic spacer to improve the fixation of the ceramic to the metal outer sleeve. The retaining element may include a series of axially spaced teeth. The ceramic spacer may also include a circumferential overhang that partially wraps around the outer surface of the outer sleeve. This can improve the fixation of the ceramic to the sleeve and increase the distance between the active and return electrodes for an improved electrosurgical tissue effect. The outer sleeve edge may form part of the return electrode. The inner shaft can also have a cavity that forms part of the fluid suction element, and thus can remove tissue that is pulled out through the window of the outer sleeve while the device is mechanically excising the tissue. , The fluid and plasma by-products drawn out through the active electrode can be removed while the device is electrosurgically treating the tissue.

Further embodiments disclosed herein include a system for mechanically excising tissue and performing electrosurgical treatment of the tissue. The system includes a motor drive unit and a blade that may be removable for the motor drive unit. The motor drive unit and blades can each form part of a fluid suction conduit that communicates with each other. The system also includes a motor drive unit controller that communicates with the motor drive unit, a fluid suction controller that controls the flow rate through the motor drive unit and the blade fluid suction conduit, and an RF generator that telecommunicationss with the blade's active and return electrodes. ,including. The blade has an outer sleeve that includes an inner sleeve that is concentrically disposed internally, the inner sleeve being coupled to a motor drive unit, thereby driving the inner sleeve and mechanically cutting the tissue. To move the inner sleeve relative to the stationary outer sleeve. The outer sleeve has an exposed conductive portion coupled to an RF generator, sized to act as a return electrode. The outer sleeve also includes a ceramic spacer that extends through the lateral opening of the outer sleeve and replaces a portion of the outer sleeve, the ceramic spacer being coupled to the outer sleeve and electricalizing the active electrode from the outer sleeve. Separated.

The fluid suction controller can also be communicably coupled to the motor drive unit controller and RF generator, thereby controlling the flow rate at the first flow rate when the motor drive unit controller is in operation, and the RF generator The flow rate is controlled by a second flow rate different from the first flow rate during operation. This second flow rate can be a variable flow rate adjusted in response to the sensed parameters associated with the electrode circuit impedance of the blade.

Further embodiments disclosed herein include a composite medical device for removing and treating a patient's tissue, including a reusable handle portion and a blade portion selectively connectable to the handle portion. obtain. The blade portion includes an outer sleeve having a lumen including an inner shaft inside, and the inner sleeve is coupled to a motor drive unit disposed within the handle portion. The inner sleeve rotates and is joined to mechanically cut the tissue. The outer sleeve may include at least one electrode for electrosurgical treatment of the tissue. The reusable handle portion includes at least one control switch that telecommunications with the motor drive unit to control the parameters associated with the rotation of the inner shaft. The blade portion may also include a switch assembly that telecommunications with at least one electrode, the switch assembly extending from the proximal end of the blade portion. The switch assembly may be selectively coupled to a reusable handle using mounting means. The switch assembly may include or be formed from a flexible substrate having first and second opposite sides, a mounting means on the first side and a second side of the flexible substrate. Along with at least one button, a conductive element is operably connected to a button for selectively coupling the at least one electrode to the output of the electrosurgical generator. The switch assembly mounting means may include an adhesive, or a clip, or a sleeve, or a wrap. The button can be a series of buttons or controls and can operate to electrically connect two electrical contacts so that the electrosurgical generator delivers energy to at least one electrode when the button is closed. possible. The button can be a series of buttons or controls, when the button is closed, the fluid control device regulates the flow of fluid along the blade portion lumen and also controls the delivery of energy to at least one electrode. As such, it may be possible to operate to electrically couple the two electrical contacts. The switch assembly may include two buttons for selecting between two tissue treatment modes, each tissue treatment mode comprising a combination of energy delivery and fluid flow rate of fluid along the lumen of the blade portion.

Further embodiments disclosed herein may include a system for mechanically excising tissue and performing electrosurgical treatment of the tissue. The system may include a motor drive unit and blades selectively coupled therein, each of which has a fluid suction conduit in which the motor drive unit and blades communicate with each other. The system may also include a motor drive unit controller that communicates with the motor drive unit and a fluid suction controller that is configured to control the flow rate through the motor drive unit and the blade fluid suction conduit. The system may also include an RF generator that telecommunications with the active and return electrodes of the blade. The blade may include an outer sleeve with an inner sleeve concentrically disposed inside, such that the inner sleeve is coupled to the motor drive unit and moves relative to the outer sleeve to mechanically cut the tissue. It is configured. The inner sleeve can rotate relative to the outer sleeve. The outer sleeve may have a return electrode and an active electrode on the outer surface of the outer sleeve at the distal end of the blade. The blade may also include a switch assembly that telecommunicationss with the return and active electrodes, the switch assembly extending from the proximal end of the blade and mounting for selective mounting of the switch assembly on the outer surface of the motor drive unit. Including means. The switch assembly is operably connected to a flexible substrate having first and second opposed sides, a button on the second side of the flexible substrate, and a button, and at least within the substrate. It can be formed from partially disposed conductive elements. The conductive element can be a series of wires for selectively coupling the active and return electrodes to the output of the electrosurgical generator. The blade may include a cable for electrically coupling the blade to the RF generator, and the button may be operably coupled to the cable. The switch assembly mounting means can be either an adhesive, a clip, a sleeve, or a wrap on a portion of the switch assembly. The button can operate to electrically couple the two electrical contacts so that when closed, the RF generator delivers energy to the active and return electrodes. The switch assembly may include two buttons for selecting between two tissue treatment modes. The button can operate to electrically couple the two electrical contacts so that when closed, the RF generator delivers energy to the active and return electrodes, as well as the motor drive unit and blades. Adjust the flow rate through the fluid suction conduit.

Detailed Description The following discussion is intended for various embodiments. One or more of these embodiments may be preferred, but the disclosed embodiments should not be construed as limiting the scope of the present disclosure, including the claims, or otherwise. Should not be used as such. In addition, one of ordinary skill in the art will appreciate that the following description has a wide range of uses, and the discussion of any embodiment only means that it is an example of that embodiment, and the patent. It is not intended that the scope of the present disclosure, including the claims, will be limited to that embodiment.

The present disclosure may generally include systems that combine mechanical resection with electrosurgical tissue treatment, including but not limited to electrosurgical tissue treatment, tissue ablation, cutting and coagulation of a single device. Combining these two modalities can reduce the need for multiple instruments during surgery, such as endoscopic or arthroscopic surgery. The mechanical blade edges of both the stationary and rotating members preferably contain metal. The active and return electrodes are preferably both disposed on the stationary outer sleeve portion of the blade for reliable and simpler telecommunications between the electrode and the energy source. The electrodes are also integrated with or form a portion of the outer sleeve portion so as to minimize the outer diameter of the blade.

An overview of the surgical system 100, best seen in FIG. 1, includes a composite device 110 having a motor drive unit (“MDU”) 112 mechanically coupled to a blade 114. The composite device 110 may be configured and operate like a commercially available metal shaver or burr having a fast rotating inner shaft disposed within a stationary outer sleeve. The composite device 110 also includes an RF bipolar power cord 116 electrically and mechanically coupled to the blade 114 for supplying RF power to the blade 114. The surgical system 100 further includes a control box 120 for powering the MDU 112 through the power cord 130 and an RF generator 140 for powering the blades 114 through the RF power cord 116.

Further, the device 110 includes a suction tube 210 extending along the MDU 112 that can be coupled to the suction control mechanism 220. The suction control mechanism 220 may control the fluid flow through the tube 210 and may be a suction pump or a plurality of suction pumps (not shown), a rotor or the like to provide and control suction of tissue and fluid. It may be a fluid pump having the device of. As a further example, the suction control mechanism may include a pinch valve having multiple positions to pinch or release the suction tube, or the control mechanism modifies the fluid conduit size (orifice) associated with the suction tube. May include means. The suction control 220 may communicate (141) with the controller of the RF power supply 140, or may communicate with the control box 120, which will be discussed in more detail later. Although the control box 120, the generator 140, and the suction control 220 are represented as separate enclosures, they may be incorporated into a single enclosure in some embodiments. In an alternative embodiment, the control box 120 and the generator 140 may each have their own dedicated suction control system, as well as associated tubing and fluid flow control means. In an alternative embodiment, the suction can be controlled at least partially by a control valve disposed on the MDU 112, which selectively enables stronger suction and reduces it during use. Can be done. In this embodiment, the suction control 220 can be manually modified by the user by supplying a constant suction flow rate and, for example, pressing a valve to change the suction rate.

The blade 114 extends through the blade 114 and includes a lumen that communicates with the suction tube 210 for suction at the distal portion 230, whereby fluid and debris can be aspirated through the window of the distal portion 230. It flows along the lumen and through the tube 210. The blade 114 includes a distal portion 230 that is inserted into the patient's body to mechanically cut the tissue and perform electrosurgical treatment of the tissue. The blade 114 includes a proximal portion 240 configured to selectively connect and disconnect the blade 114 to the MDU 112 and to mechanically engage a portion of the blade 114 with a motor in the MDU 112.

The control box 120 is described in, for example, Andover, Mass's Smith & News, Inc. It can be the Dynamics® Power Sheber System or the Dynamics® EP-18 Sheaver System supplied by. The generator 140 can be, for example, a commercially available generator such as the COBRATION WEREWOLF system supplied by Andover, Smith and Nephew of Mass, Inc. The blade 114 is sized to fit the desired application. For example, for use on the shoulder, the blade is sized differently than the blade for use on the prostate. Applications include use in, for example, shoulders, knees, and other joints, as well as in natural foramen such as the uterus, urethra, nasal passages, and mouth.

Referring to FIG. 2, the RF power cord 116 may be terminated at the free end having the connector 320. The connector 320 may have at least two protrusions 322 and 324 designed to connect to either the generator 140 or the footswitch. Each protrusion connects to one of two separate conductors in the RF power cord 116 to provide both a supply path and a return path for the blade 114. Additional protrusions (not shown) may provide the RF generator / controller 140 with additional information such as device type and / or desired or candidate settings such as fluid flow settings or power settings. The alternative connector is to connect to the connector of the RF controller 140, such as the system described in US Pat. No. 9,333,024 by the same assignee, the entire disclosure of which is incorporated herein by reference. It may include a set of configured pins.

MDU 112 includes a drive shaft (not shown) configured to selectively connect to the proximal end of the blade 114, the entire disclosure of which is incorporated herein by reference in the United States Patent No. 1 by the same assignee. It may include binding means similar to those disclosed in 7,150,747.

The suction controller 220 has the MDU control box 120 and the RF generator 140 represented in FIG. 1 so that the suction rate can be controlled by the fluid flow rate regulated by the control box 120 during the time the MDU is in operation. Can communicate with both. This can be further dynamically modified in response to the perceived parameters associated with the MDU, or the perceived temperature within the patient's joints. In addition, during the time the RF generator 140 is in operation, suction can be controlled by the fluid flow rate commanded by the RF generator 140. The fluid flow rate was sensed, such as the electrode circuit impedances described in US Pat. Nos. 8,192,424 and 9,333,024 by the same assignee, the entire disclosure of which is incorporated herein by reference. It can be changed more dynamically in response to the parameters.

In general, the blade 114 mechanically excises in a manner similar to other commercially available mechanical excision devices, in which case the blade 114 is an outer sleeve that is fixedly attached to the MDU 112 and is a stationary sleeve in use. It comprises a 310 and an inner sleeve 410 concentric with the outer sleeve coupled to the MDU 112, whereby the inner sleeve 410 can rotate at high speed with respect to the stationary outer sleeve 310. The blade 114 can be attached to the MDU 112 using various structures such as threaded connections and press-fit connections. Various embodiments of MDU112 are described in Andover, Mass & Smith & News, Inc. Includes motor drive units manufactured by, for example, part numbers 7205354, 7205355, 7205971 and the like.

Various cutting surfaces can provide mechanical cutting. Such surfaces include, for example, curved, burred, linear, wavy, or small blades. Mechanical cutting is typically achieved at speeds of thousands of cycles per minute (eg, rotation or reciprocation).

Here, referring to FIGS. 3A-3D showing embodiments of the blade distal tip 340, the outer sleeve 310 includes a longitudinal opening 320 and defines an edge surface 325 around at least a portion of the outer circumference of the opening 320. do. The edge 325 is preferably sharp enough to cut tissue when used in combination with the inner sleeve 410. The inner sleeve 410 may have a similar opening 420 and edge 425 configured to cooperate with the edge 325 to mechanically excise the tissue as the inner sleeve rotates. The inner sleeve 410 and opening 420 may communicate with the suction tube 210 such that the inner sleeve 410 defines an elongated fluid conduit along its lumen (not shown), thus forming during mechanical excision. The necrotic tissue pieces that have been removed can be removed through the conduit and opening 420. Both the inner and outer sleeves (410 and 310) include their cutting edge surfaces 425 and 325 and can be formed from a metal such as stainless steel, which makes this material generally of good strength and durability. This is because the inventors have found that they propose a cutting edge. One alternative option for the sleeve can be Invar, a nickel-iron alloy that is easily brazed. Metal cutting edges are preferred to reduce particle formation during cutting, which can occur with more brittle materials.

The outer sleeve 310 is preferably a metal or conductive tube configured to provide an electrical path from the electrical cord 116 to the distal tip of the blade. The outer sleeve 310 may be at least partially coated or coated by a layer or sheath 305 to electrically insulate a portion of the outer sleeve 310 and limit the exposed portion of the outer sleeve to a controlled area. For example, the proximal portion of the outer sleeve 310 adjacent to the MDU 112 can be electrically coupled to the cord 116 and thereby sufficiently exposed to electrically coupled to the RF generator 140 (not shown). The distal portion of the outer sleeve 310 can also remain exposed, so that the metal cutting edge 325 is exposed for mechanical excision and thereby for use during the application of RF energy. The surface area defining the return electrode 350 of the system 100 is exposed.

The outer sleeve 310 further comprises an active electrode 360, which is electrically coupled to the RF generator 140 via a cable or wire (not shown) and electrically insulated from the outer sleeve 310, thereby providing an electrically insulating spacer 370. It is electrically isolated from the return electrode 350 via. The spacer 370 is preferably an electrically insulating material that is resistant to decomposition from plasma or plasma curing, as the active electrode 360 is intended to selectively cauterize the tissue and thus form plasma. The material may include a ceramic or glass material such as alumina, zirconia. Preferred embodiments may use inherent high strength and fracture resistant ceramics such as zirconia. This ceramic can be molded into the same detailed shape as alumina, but does not decompose under plasma like conventional zirconia. Silicon nitride is an additional option.

In addition, the active electrode 360 should preferably be a material resistant to plasma degradation, such as tungsten, titanium, platinum, molybdenum, aluminum, gold, and copper. More specifically, the active electrode can preferably be a different material than the inner and outer sleeve materials. Stainless steel is preferred for mechanical cutting edges, but stainless steel is not a preferred material for cautery electrodes because it tends to be less resistant to plasma degradation. In addition, for example, tungsten is a more brittle metal than stainless steel and is therefore not preferred as a cutting edge because particles can form during mechanical cutting. In addition, the inventors should separate the distal end portion that forms the plasma from the mechanical cutting edge, and whatever the material of choice for the mechanical cutting edge, the edges are decomposed by the plasma. It has been found that the mechanical cutting may be impaired. The minimum distance between the peripheral edge of the active electrode 360 and the cutting edge 325 should be at least 2 mm, as irregularities such as sharp edges are more likely to form plasma on it. The portion of the distal end that forms the plasma should be separated from the mechanical cutting edge, so that plasma formation along the mechanical cutting edge is not preferred.

To maintain the smaller outer diameter of the distal tip 340, the spacer 370 may replace a portion of the outer sleeve 310 so as to extend from the outer surface towards the inner lumen through the wall thickness of the outer sleeve 310. .. In other words, the outer sleeve 310 comprises a second opening 330 through which the spacer 370 is received. The opening 330 can be an enclosed opening separated from the cutting edge 325 and the most distal tip of the outer sleeve 310, and can be at least a partially diametrically opposed opening 320. The opening 330 preferably axially overlaps the opening 420 of the inner sleeve. The spacer 370 is preferably formed of a high-strength ceramic that provides structural integrity to the outer sleeve 310 and may add rigidity to the outer sleeve to provide a strength improvement compared to all metal outer sleeves. The insulating spacer 370 is not used as a cutting surface, but instead serves to seal the metal inner sleeve 410 and provide separation from the plasma. The spacer 370 extends through the second opening 330, but preferably does not extend into the outer sleeve lumen because the spacer 370 can interfere with the inner sleeve 410 as the inner sleeve 410 rotates. Or do not invade. Best seen in FIG. 3C, the spacer 370 may extend through the second opening 330 to the inner lumen wall 312 of the outer sleeve 310. The inner curved surface 371 of the spacer 370 can be curved so as to be substantially continuous with the curvature of the inner lumen wall 312. Replacing a portion of the outer sleeve 310 with a spacer 370, as compared to a spacer that can only be located on the outer surface of the outer sleeve 310, allows a significantly smaller cross section to be maintained overall (FIG. 3C). (See), while still maintaining the spacing requirement between the active and return electrodes to control the electrical path between the two electrodes. Therefore, according to the disclosed spacer configuration, a minimal increase to the outer cross section of the device is achieved. For example, we found that when the outer diameter (OD) of the outer sleeve is approximately 4.5 mm, similar to existing devices such as the Platinum Bonecutter, the maximum cross section (CS) including the spacer 370 and electrodes 360 is. It was found to still fit through a 5 mm cannula.

Further details of the spacer 370 and the active electrode 360 are best seen in FIGS. 4A and 4B showing exploded views of the upper and lower parts of the distal portion 340. The second opening 330 extends through the inner lumen of the outer sleeve 310, and the inner sleeve 410 can be seen through the second opening 330 in FIGS. 4A and 4B. The inner sleeve 410 is preferably oriented so that the inner sleeve opening 420 is in fluid communication with the second opening 330 during the operation of the RF generator 140. In other words, the inner sleeve opening 420 may preferably face the second opening 330 during the operation of the cautery mode. (The figure shows the inner sleeve opening 420 pointing away from the opening 330). In some modes, does this inner sleeve opening 420 only partially overlap the second opening 330 as a means of controlling fluid flow through the active electrode 360, spacer 370 and second opening 330? , Or can be rotated to adjustably overlap the second opening 330. This can further control the tissue effect and energy in any plasma formed by the active electrode 360, as described above. Alternatively, the inner sleeve opening 420 may be aligned with the second opening 330 and the volumetric flow rate may be controlled using a flow control device such as a pump that communicates with the controller 220.

The second opening 330 may include mechanical locking features 335, such as a plurality of axially spaced teeth, in order to better bond the spacer 370 to the outer sleeve 310. Complementary retention features 375 can be seen on spacer 370 in FIG. 4B, and tooth formation is configured to improve the stress distribution between the two components. Bond strength can also be improved due to the increased contact area. The spacer holding feature 375 can penetrate into the spacer 370 surrounded by the overhang 380 and is found in both FIGS. 4B and 3C. This overhang 380 offers several advantages. First, the stress is better distributed between the spacer 370 and the outer sleeve 310 due to any lateral load during use of the device. It also increases the surface area contact between the spacer 370 and the outer sleeve 310, which adds an area for the adhesive junction. In addition, this overhang 380 provides a preferred electrical insulation gap between the return electrode 350 and the active electrode 360, thus improving plasma formation around the active electrode 360. The gaps are shown in FIGS. 3B and 3C as intervals X and Y. If the distance between the two electrodes is too small, the accumulation of high voltage forming the plasma can be destroyed and an electrical short circuit can occur. In addition, the contour or fringe 381 of the overhang follows the fringe surface contour of the cut window 325 to maintain visibility of the window 325 and limit the visibility blocked by the ceramic spacer 370.

The spacer 370 includes a suction opening 372 through the thickness of the spacer 370 so that it communicates fluidly with the inner lumen of the outer sleeve 310. As mentioned above, suction of fluid, plasma, and coagulation by-products occurs when the inner sleeve opening 420 is oriented to at least partially face or communicate with the suction opening 372. It can be removed from the tissue treatment site, allowing the same suction pathway to be used for both mechanical resection and RF tissue treatment. Typically, this requires that the active electrode 360 be offset more away from the return 350 to prevent plasma from forming inside the device. (The distance between activity and return inside the device should preferably be greater than the distance between activity and return on the outer surface of the device). Here, since the inner portion of the outer sleeve 310 is replaced by the insulating spacer 370 (curved surface portion 371), the distance from the active electrode 360 to the return 350 (surface 312) is here increased, thereby the device. Minimize the inner unintended plasma. The active electrode 360 also includes at least one suction opening 362 that fluidly communicates with the suction opening 372 of the spacer 370 to remove debris and plasma by-products through the surface of the active electrode during use. The active electrode 360 has a rounded outer surface and nesting within the spacer cavity 376, minimizing any additional size increase so that the device can fit within a 5 mm cannula. The active electrode 360 is constrained and supported by a ceramic spacer 370 by a slot 373 on the lateral side of the cavity 376 and a bilateral overhang 374. The electrode flange or tail 363 slides into the slot 373 in the spacer 370, and the lateral portion of the electrode 360 is partially covered by the overhang 374. The overhanging portion 374 further increases the distance between the active electrode 360 and the return electrode 350. This type of mechanical interface is possible by using a metal injection molded electrode 360, ideally made primarily of tungsten. The flange 363 is conductive and forms part of the electrical path from the active electrode 360 to the RF generator. The flange 363 can be a molded portion of the electrode 360 so that the flange 363 and the electrode 360 are a single molded part. Alternatively, the flange 363 may be a conductive wire or cable electrically coupled to the electrode 360. A conductive cable or flexible circuit (not shown) may be electrically coupled to the flange 363 or electrode 360 and extend along the outer sleeve 310 to the proximal portion of the blade 114 and the electrical cord 116. The conductive cable is electrically separated from the outer sleeve 310 because the outer sleeve 310 preferably provides a conductive path for the return electrode 350 to the cord 116.

The active electrode 360 may have a concave lower 364. This increases the distance between the active electrode 360 and the inner sleeve 410, preventing the inner sleeve 410 from unintentionally acting as an electrical path shunt in several orientations, thereby affecting plasma formation. do. This can occur if the active electrode is not concave or is too close to the metal inner sleeve 410. As mentioned above, the distance between the inner surfaces of the active and return electrodes should preferably be greater than the distances X and Y on the outer surface portion so that a consistent plasma is formed on the outer surface of the active electrode 360. Is. There may be no electrical insulation means between the inner and outer sleeves (410 and 310, respectively) while the outer sleeve 310 is coupled as a return electrode. Considering that the inner sleeve may come into contact with the outer sleeve in several places, the inner sleeve 410 may be electrically coupled to the outer sleeve, thereby forming part of the return path. Therefore, it would be hypothesized that the inner sleeve 410 could operate to form part of the conductive path as the inner sleeve 410 contacts the inner lumen of the outer sleeve 310. Thus, the inner sleeve 410 may bridge or short circuit the electrical path between the active electrode inner surface 364 and the return electrode 350 when the inner sleeve is in a particular orientation, such as the orientation shown in FIG. 4A. When the inner sleeve 410 is rotated as shown in FIGS. 4A and 4B, the distance between the inner surface 364 and the outer surface of the inner sleeve 310 is preferably the distance X and / or Y as described in FIGS. 3B and 3C. Should be farther away. The concave inner surface 364 is one means of achieving this minimum spacing. Alternative means include the bosses described in the figures below.

The active electrode has a distal tip 368 that can extend around the rounded distal tip of the outer sleeve to minimize the device cross section while also providing an RF tissue effect at the distal tip of the device. .. The distal tip 368 can also be tapered to minimize the overall diameter at the tip for improved access to smaller areas. The outer curved surface also minimizes tissue dehiscence by manipulating the device, along with the recessed position of the active electrode 360 within the spacer 370. In addition to reducing dehiscence, the distal ends of the blade should include components that transition smoothly from each other and preferably have a curved and smoothed outer shape. It maintains the feel or tactile feedback of the device similar to the device the surgeon is accustomed to, such as pure mechanical excision devices only. Tactile feedback is important for the feel of the device while mechanically excising the tissue or generally manipulating the tissue.

Suction through the active electrode 360 and spacer 370 can be controlled by the shaver's "window locking" feature. The surgeon has the ability to set the opening 420 of the inner sleeve 410 to "closed", thereby allowing flow exclusively through the active electrode 360 and through the opening 362. This may be necessary to clean the area of air bubbles generated during RF plasma ablation. Laser marks may be added to the inner and / or outer sleeves to indicate alignment when the opening 420 is closed. By sharing the suction channel with the mechanical excision handle, the surgeon can also customize the ablation performance by controlling the suction on the handle. The suction openings 362 and 372 best seen in FIG. 3D can be angled and slightly axially offset from each other. This can help direct the flow or debris and by-products proximally.

FIG. 5A shows an alternative embodiment isometric view for the distal portion of the blade. Similar to the above embodiments, the distal portion of the blade comprises an inner sleeve 510, an outer sleeve 520, an active electrode 560, and a spacer 570. Both the outer sleeve 520 and the inner sleeve 510 may have openings with sharp edges for mechanically cutting tissue. The active electrode 560 may be electrically coupled to the RF generator 140 via a cable or wire and electrically insulated from the outer sleeve 520, thereby being electrically insulated from the return electrode 550 via an electrically insulating spacer 570. Similar material factors, such as plasma curable and durable cut surfaces, are considered for spacers, outer sleeves, and active electrodes 560, as described in the above embodiments.

To maintain a smaller outer diameter of the distal portion, the spacer 570 extends from the outer surface toward the inner lumen or to the inner lumen through the wall thickness of the outer sleeve 560. It can replace a portion of 560. The opening 530 may be an enclosed opening separated from the cutting edge 525 and the most distal tip of the outer sleeve 520. The spacer 570 is preferably formed of a high-strength ceramic that provides structural integrity to the outer sleeve 520 and may add rigidity to the outer sleeve 520 to provide strength improvement. The insulating spacer 570 is preferably not used as a cutting surface, but instead serves to seal the metal inner sleeve 510 and provide separation against RF ablation plasma. The spacer 570 extends through the opening 530, but preferably does not extend into the outer sleeve lumen or extends into the outer sleeve lumen because the spacer 570 can interfere with the inner sleeve 510 as the inner sleeve 510 rotates. Do not invade. Best seen in FIGS. 5B and 5C showing a cross section of FIG. 5A, the spacer 570 can extend through the opening 530 towards, but not beyond, the inner lumen wall of the outer sleeve 520. The inner curved surface of the spacer 570 can be curved so as to be substantially continuous with the curvature of the inner lumen wall 512. By creating this hybrid tip, a significantly smaller cross section is maintained overall with a spacer 570 that replaces a portion of the outer sleeve 520 (see FIGS. 5B and 5C). Therefore, according to the disclosed spacer configuration, a minimal increase in the outer cross section of the device is required. For example, we found that when the outer diameter (OD) of the outer sleeve is approximately 4.5 mm, similar to existing devices such as the Platinum Bonecutter, the maximum cross section (CS) including the spacer 570 and electrode 560 is. It was found to still fit through a 5 mm cannula.

Although not shown in FIGS. 5A-5C, openings 530 and spacers 570 may include mechanical locking features similar to those described in FIGS. 4A and 4B. The spacer 570 is also found in both FIGS. 5B and 5C to improve the stress distribution between the spacer 570 and the outer sleeve 520 due to any lateral load during use of the device, overhang 580. May include. The overhang 580 can also increase the surface area contact between the spacer 570 and the outer sleeve 520, which adds an area for the adhesive junction. In addition, this overhang 580 provides a preferred gap between the return electrode 550 and the active electrode 560 in order to form a consistent plasma at the active electrode 560, the gaps as intervals X and Y in FIG. 3B. And similar to those shown in 3C.

The spacer 570 includes a suction opening 572 that passes through the thickness of the spacer 570 that communicates fluidly with the inner lumen of the outer sleeve 520. In this embodiment, the suction opening 572 includes a boss 573 to increase the dielectric spacing between the active electrode 560 and the effective return electrode. As described above, it is preferred that the distance between activity and return inside the device is greater than the distance between activity and return on the outer surface of the device. Here, the distance from the active electrode 560 to the return electrode 550 is increased here because the inner portion of the outer sleeve 520 is replaced by the insulating spacer 570 and the bossed openings 572, 573, thereby the device. Minimize inner unintended plasma formation. The boss 573 extends through a complementary opening 565 within the active electrode 560, nests therein and terminates slightly recessed from the top surface of the active electrode 560. It maintains an exposed rim surface around the active electrode opening 565 to focus the electric field and form a plasma at the rim of the opening 565. The suction openings 565 and boss 573 are sized to remove necrotic tissue debris and plasma by-products from the surface of the active electrode during use. The active electrode 560 has a rounded outer surface that keeps the distal tip cross section to a minimum and fits within a 5 mm cannula and is at least partially nested within the spacer cavity 576. Unlike the embodiment in the figure above, which discloses the concave underside of the active electrode, in this embodiment of the active electrode 560, the boss 572 provides an auxiliary electrical path spacing for primary electricity on the outer surface of the device. It can be flush within the spacer cavity 576 so as to prioritize the path. This can further reduce the distal tip cross section. It can also provide a better tactical feel, as mentioned above.

In addition to manual control, the device 110 may be directly connected to the Werewolf ^◇ COBRATION ^◇ System, which is owned by the same assignee of the present application and incorporated herein by reference. This may allow automatic control of suction when COBRATION is active and may provide constant or controlled suction to the shaver device when COBRATION is not active. Shaver flow control can be controlled based on various feedbacks such as pressure in the pipe, power to reverse the motor, torque converter connected to the motor, and / or motor temperature. Also, the flow control module can be operated in the opposite direction to clear the blockage.

The composite device 110 may also have a solidification mode, which is generally characterized as a lower voltage mode compared to the cauterization mode. The coagulation field of the device 110 is included in the area around the active electrode 360. This controlled area reduces unintended thermal tissue damage.

The electrical path of this device may use the outer flexible circuit of the outer sleeve 310 for power delivery to the active electrode. This same flexible circuit may be incorporated to enable ^Ambient technology, which is owned by the same assignee of the present application and is incorporated herein by reference. Ambient technology provides temperature information to the RF controller and / or control box 120, thereby sensing a value indicating the temperature of the fluid in the joint during both mechanical excision and RF tissue treatment. The sensor for sensing a value indicating temperature can be coupled to any portion of the device distal tip 340, eg, to a portion of the spacer axially spaced proximally from the active electrode.

An alternative embodiment of the blade distal portion 600 is shown in FIGS. 6A and 6B and includes a dedicated suction channel 650 for operation while delivering RF energy to the blade distal portion 600. Features such as cut windows or openings and return electrodes may be similar to the embodiments disclosed above. The suction channel 650 may be part of a spacer 670 that may extend proximally along the device shaft. In this embodiment, the suction pathway is separated from the mechanical excision suction pathway, extends along the outer portion of the device, and is a separate suction tube directly coupled to the flow control device associated with the RF control device only ( (Not shown) and connect. This may allow for a more customized suction profile and thereby more customized ablation performance (eg, using the Werewolf Flow Control module or similar method). Also noteworthy is that the active electrode 660 may include a plurality of suction openings 672, each of which has a different shape.

Further alternative embodiments of the blade distal portion 700 are shown from various angles in FIGS. 7A, 7B, and 7C. Features such as cut windows or openings and return electrodes may be similar to the embodiments disclosed above. This embodiment includes a shield or central tube 730 in addition to the inner tube 720 and outer tube 750. Similar to the above embodiment, the active electrode 760 may be supported by a spacer 740 coupled to the outer tube 750 to provide a return path for RF output. This device is similar to an "Orbit" style shaver. The shield of the central canal 730 can be used to control the suction, thereby preventing the need to set a "window lock" to control the suction. As shown in FIG. 7A, the shield 730 is in an open configuration and the inner tube 720 can rotate relative to the shield 730 to mechanically excise the tissue and aspirate necrotic tissue pieces through the lumen of the inner tube. .. In this open configuration, even when energy is supplied, there may be no suction available on the active electrode 760, which may be preferable for some tissue treatments. Note that the edges along the respective openings of the central canal 730 and the medial canal 720 provide tissue resection. FIG. 7B shows a shield in a partially open configuration that can provide some suction through the active electrode 760 as well as through the medial lumen. In this partially open configuration, mechanical resection and electrosurgical tissue treatment can be used in combination or sequentially. This configuration can also be configured to control the suction rate. In the third and closed configurations, the shield 730 may be rotated to completely cover the inner tube 720 and have an opening facing the underside of the active electrode 760. Suction can be provided primarily through the active electrode 760 to the opening.

A further alternative embodiment of the blade distal portion 800 can be seen in FIG. This embodiment may include an axially slidable electrode 860, which is removed from a very close area around the distal tip during mechanical resection, after which electrosurgical tissue treatment is desired. Can slide over the suction opening 850 when done. Multiple suction holes 865 are shown in this embodiment, and other embodiments described above that may provide an alternative suction path for reducing clogging.

The composite device can operate in various modes. For example, in the first mechanical excision mode, the MDU 112 may rotate or move the inner sleeve 410 to mechanically cut the tissue, similar to other shaver devices. During this mode, excised tissue can be removed from the patient through the opening 420 and along the lumen within the inner sleeve coupled to the suction source. Suction can be controlled, for example, by a suction controller 220, which can control the speed or rotation of the peristaltic pump. Alternatively, the vacuum source may be coupled to a suction tube and the suction controller may move the pinch element or selectively close the valve. Alternatively, the suction controller may include a movable construct having a first body with one or more openings and a second body with one or more openings, thereby the first and first. One or more of the two bodies can be moved relative to the other so that the alignment between the first and second body openings can be changed to change the flow rate. Suction can be controlled by a first flow rate during excision, which, as a non-limiting example, is associated with motor speed settings, sensed electrical parameters associated with the MDU, and devices. It can be adjusted by the user or automatically, depending on various parameters such as temperature.

In a second mode, electrosurgical mode, the inner sleeve 410 can be stationary and the window 420 is laterally opened to provide a suction conduit during electrosurgical treatment such as cauterization or coagulation, or a combination of both. Can face part 330. During this second mode, the active electrode 360 may be placed adjacent to the target tissue and RF generator for electrosurgical treatment of the tissue. The fluid, tissue, and / or plasma by-product includes passing through the opening 362 of the active electrode 362, through the spacer opening 472, through the inner sleeve opening 420, and along the inner sleeve 410. , Along the path, can be removed at the same time. Suction can be controlled by a suction control system such as a peristaltic pump or device that involves controlling the size of the fluid conduit or opening communicating with the inner sleeve suction lumen. The suction control system can communicate with the RF generator. Communication may be wireless. Suction may be adjusted by the user, or automatically set and adjusted based on operating parameters such as power settings on the RF generator, or based on sensed parameters such as electrode circuit impedance. May be good. Further explanations for this can be found in U.S. Pat. Nos. 8,192,424, 9,333,024, and 9,713,489 by the same assignee, the entire disclosure of which is: , Incorporated herein by reference. Suction can be adjusted via control of pump speed, valve position, or above-mentioned orifice size control associated with the suction controller. In addition, suction can be controlled by adjusting the position of the opening 420 with respect to the opening 330, which can regulate effective suction through the active electrode opening relative to passing through the suction conduit. Alternatively, this second mode may be a coagulation mode that includes a lower voltage output configured to coagulate the tissue rather than dissociate the tissue.

Alternatively, this second mode may include some degree of simultaneous coagulation with tissue cauterization. This can be achieved by adjusting the output of the RF generator. This further description can be found in patent application No. PCT / US18 / 032989 by the same assignee, the entire disclosure of which is incorporated herein by reference. Alternatively, this regulation may be achieved through pulsed suction through the control of a suction control system such as a peristaltic pump or by continuous rotation of the inner sleeve while delivering RF. The controlled rotation of the inner sleeve may regulate the suction through the active electrode opening 362, which in turn can form and disintegrate a plasma on the surface of the active electrode. The voltage supplied by the RF generator is a constant high frequency voltage level and may be sufficient to form plasma on the electrode surface while rotating the inner sleeve 410. For example, when the inner sleeve 410 is oriented to block suction through the active electrode, plasma is formed on the surface of the active electrode to provide ablation of the tissue. When the inner sleeve 410 is oriented to draw fluid through the active electrode opening 362, the energy supplied by the RF generator is not sufficient to form the plasma and thus provides a coagulation effect on the tissue. obtain. The rate at which the suction rate adjustment occurs is perceived by the user as having a consistent tissue effect, but is preferably fast enough so that it is slow enough to allow the plasma to form intermittently. .. The rotation of the blades may be continuous, or the blades may alternate intermittently between several positions that will affect the flow through the active electrode. To control or limit the simultaneous mechanical excision of the tissue, the inner sleeve is preferably such that the cutting edge of the inner sleeve is not exposed through the outer sleeve cutting window and the tissue is not unintentionally cut mechanically. It can go back and forth. Synchronized voltage modulation also has a first voltage sufficient to form the plasma and a second voltage that can help the plasma to collapse due to some communication between the required inner sleeve orientations. Can be added during.

During this simultaneous mode, a slower rotation speed than during mechanical excision may be desirable in order to control the frequency of plasma formation and decay. The suction rate is such that when the suction through the active electrode is maximum (when the inner sleeve opening 425 directly faces the active electrode), the plasma collapses and the plasma is reduced from reshaping (suction). A first configuration for the active electrode, a suction opening through it, and a first configuration of the applied voltage so that the opening 425 rotates away facing the underside of the active electrode). Can be set to the flow rate of. Alternatively, the suction flow rate can be more moderate with respect to the second configuration of the active electrode having a suction opening through the active electrode, and the voltage is the maximum moderate suction (inner sleeve opening 425 directly to the active electrode). When facing) assists in the formation of the plasma and allows the plasma to decay at a lower suction rate (when the opening 425 rotates away facing the underside of the active electrode). , Can be supplied.

In the third combined mode, RF power can be supplied simultaneously while mechanically cutting the tissue. RF power may be supplied at a voltage sufficient to coagulate the tissue in order to improve visibility (reduction of blood in the region). This can also reduce the need for the surgeon to stop and activate the RF generator separately when looking at the blood or when the tissue needs to be cauterized. Alternatively, if more aggressive cleavage is desired, RF power may be adequately supplied to simultaneously cauterize the tissue while mechanically excising the tissue. In this third mode, if more consistent plasma formation is desired, a separate suction conduit for the electrodes, which is different from the inner sleeve lumen, has a more consistent fluid suction rate, and thereby more consistent. It may be preferable to maintain plasma formation. Suction can be controlled by two suction controllers, or at least two pumps associated with a single controller, the first pump is controlled based on the input from the MDU control and the second pump is RF. It is controlled in response to the input from the generator. Suction may be adjusted by the user or automatically set based on operating parameters such as power settings on the MDU controller and / or RF generator, or based on sensed parameters such as electrode circuit impedance. And may be adjusted. Further explanations for this can be found in U.S. Pat. Nos. 8,192,424, 9,333,024, and 9,713,489 by the same applicant, the entire disclosure of which is: , Incorporated herein by reference.

See here, FIGS. 9A and 9B, showing an embodiment comprising a blade portion 114 including a disposable hand switch 900 having buttons and controls 905 for use with a combined surgical device. Similar components are given similar numbers as in the figure above. A composite device containing a second modality is not available through the reusable handle 112 because the reusable handle 112 can be used as an alternative to a non-composite device that provides only electric excision. May require means. One option described so far is the use of footswitches. An alternative option, which may be preferred to the user, is a hand switch that can be attached to the handle of a reusable device (shown in FIG. 9B), such as a combined surgical device for controlling (RF) radiofrequency treatment. Offering option 900. This may be in the form of an RF generator control button 905 electrically coupled to the RF generator (140) via the RF generator cable 116. When opening the disposable package containing the blade portion 114 with the hand switch 900, the user may couple the blade portion 112 to the handle 112 and then place the disposable hand switch 900 on the desired portion of the reusable handle 112. .. The disposable hand switch 900 may be removably secured to the MDU 112 using, for example, a binding means such as an adhesive, or a clip that at least partially surrounds the MDU 112. The coupling means may be operational to prevent unintended relative movement between the hand switch 900 and the reusable handle 112. When the procedure is complete, the disposable hand switch 900 can be removed with the blade portion 114 for disposal.

In one exemplary embodiment, the inventor envisions a single strip button 905 that is overmolded or placed in a rubber or elastomer mat. The button 905 can operate to close the electrical circuit or pair of contacts upon activation of the button 905 to allow electrical energy to be delivered between the electrodes of the blade portion 114. A cord 910 or more preferably an extension of the overmolded rubber mat may physically bond the disposable blade 114 to the button 905. The cord 910 may accommodate wiring for selective telecommunications between the blade 114 and the generator cable 116 and may electrically insulate the wires. The hand switch 900 may be coupled to any portion of the blade portion 114 and the cord 910 may be long enough or extendable, allowing the hand switch 900 to be attached to the reusable handle 112. .. The hand switch 900 may be attached to a reusable handle 112 using an adhesive or adhesive strip, which may be covered while being packaged and covered by an adhesive cover 915 that is easily peeled off. This easy removal of the release cover can then expose the adhesive and then attach the hand switch mat 900 to the handle 112.

The blade portion 114 is shown coupled to a reusable handle in FIG. 9B, the adhesive cover is removed and the hand switch strip is attached to the reusable handle 112 at the desired location. It may be preferable that the handswitch 900 may be best mounted on the side perpendicular to the sides of the reusable permanent buttons 950 and 951. The inventor also envisions a "Y" -shaped strip that allows the buttons to be placed on the two opposite sides of the permanent button 951 and gives the surgeon more choice. The disposable handswitch 900 strip should be shaped to fit easily on the existing surface of the reusable handle 112, but does not have to be rectangular as shown. The disposable handswitch 900 strip is configured to attach to the distribution of devices that are easily accessible by the user. Button 910 is a first button for invoking cauterization, a second button for invoking coagulation, and US Pat. No. 8, by the same transferee, which is incorporated herein by reference in its entirety by power setting or reference. , 192,424, 9,333,024, and 9,713,489 may include a third button for circulating different modes, such as the vacuum mode detailed. The adhesive should allow strong attachment to the reusable MDU handle 112 and provide easy release at the end of the procedure. Therefore, the adhesive is configured to have sufficient water resistance to prevent peeling during the motion procedure.

In an alternative embodiment, the hand switch 900 may include a clip for selectively or temporarily fixing the hand switch 900 to the reusable handle 112. The clip may partially surround the reusable handle 112. The clip may have an inner peripheral surface configured to engage the outer surface of the reusable handle 112, and the outer diameter of the reusable handle 112 so as to better anchor the hand switch 900. Can have a slightly smaller inner diameter than. Alternatively or additionally, the inner surface of the clip may have gripping features, such as teeth or a high friction surface, to re-improve the engagement between the handswitch 900 and the handle 112. The handswitch 900 may include two clips, one at either end of the handswitch 900 to better stabilize the handswitch 900 with the reusable handle 112.

In a further alternative embodiment, the handswitch 900 may include a thin sleeve that can slide on a reusable handle, the sleeve having an opening for access to the reusable controls 950 and 951. Have. Alternatively, the handswitch 900 may include a thin wrapping element configured to wrap around a portion of the reusable handle and may include openings for exposing the reusable controls 950 and 950. .. An exemplary wrap may be completely wrapped around the handle 112 and may be attached to itself using, for example, rubbing, Velcro or adhesive. The thin wrapping element can be partially elastic to improve fixation with the reusable handle.

The above considerations are meant to be exemplary of the principles and various embodiments of the invention. Once the above disclosure is fully understood, a number of modifications and modifications will be apparent to those of skill in the art. The following claims are intended to be construed to accept all such modifications and modifications.

Claims (20)

A complex medical device for removing and treating patient tissue,
The blade portion comprises a handle portion and a blade portion, wherein the blade portion includes an outer sleeve having a lumen having an inner shaft disposed inside, and the outer sleeve mechanically structures the tissue as the inner shaft rotates. Has a window containing a cutting edge, configured to cut,
The outer sleeve defines an exposed conductive portion through which the lateral opening passes, the lateral opening being circumferentially separated from the window.
The dielectric spacer is coupled to the lateral opening so as to extend through the lateral opening.
A composite medical device in which the dielectric spacer nests the active electrode, electrically separates the active electrode from the outer sleeve, and the exposed conductive portion defines the return electrode. The composite medical device according to claim 1, wherein the dielectric spacer is ceramic. The composite medical device of claim 1, wherein the lateral opening defines a peripheral edge having a plurality of holding elements configured to be integrated with a cooperative holding element on the dielectric spacer. The composite medical device of claim 1, further comprising a circumferential overhang for the dielectric spacer to partially wrap around the outer surface of the outer sleeve. The inner shaft has a lumen that forms part of the fluid suction element, and the fluid suction element is configured to remove tissue drawn through the window while mechanically excising the tissue. The composite medical device according to claim 1, wherein the device is configured to remove fluids and plasma by-products drawn through the active electrode while the tissue is being electrosurgically treated. The composite medical device of claim 1, wherein the active electrode has a suction opening through the active electrode for removing fluid and necrotic tissue debris. 1. The blade portion further comprises an electrical switch assembly that telecommunicationss with the active electrode, wherein the switch comprises mounting means for selective mounting of the switch assembly in a desired location of the handle portion. The complex medical device described in. The switch assembly comprises a flexible substrate having first and second opposed sides, a button on the second side of the flexible substrate, and at least one electrode of the electrosurgical generator. 7. The composite medical device of claim 7, comprising a conductive element operably connected to said button for selectively coupling to an output. The composite medical device of claim 7, wherein the switch assembly mounting means is selected from the group consisting of an adhesive, a clip, a sleeve, and a wrap. A complex medical device for removing and treating patient tissue,
It comprises a handle and a blade selectively connectable to the handle, wherein the blade comprises an outer sleeve having a lumen including an inner shaft disposed therein, and the inner sleeve is disposed within the handle. It is coupled to a motor drive unit and is configured to rotate so that it mechanically cuts the tissue as the inner shaft rotates.
The blade comprises at least one electrode configured for electrosurgical treatment of tissue.
The handle comprises at least one control switch that telecommunicationss with the motor drive unit for controlling parameters associated with rotation of the inner shaft.
The blade further comprises a switch assembly that telecommunicationss with the at least one electrode, the switch assembly extending from the proximal end of the blade and mounting for selective attachment of the switch assembly to the handle. Complex medical device, including means. The switch assembly comprises a flexible substrate having first and second opposed sides, a button on the second side of the flexible substrate, and at least one electrode of the electrosurgical generator. 10. The composite medical device of claim 10, comprising a conductive element operably connected to said button for selectively coupling to an output. 10. The composite medical device of claim 10, wherein the switch assembly mounting means is an adhesive, clip, sleeve, or wrap. 10. The combined medical treatment according to claim 10, wherein the button is capable of electrically coupling two electrical contacts so that the electrosurgical generator delivers energy to the at least one electrode when closed. device. 10. The combined medical device of claim 10, wherein the switch assembly comprises two buttons for selecting between two tissue treatment modes. The button electrically couples two electrical contacts so that when closed, the electrosurgical generator delivers energy to the at least one electrode and regulates fluid flow along the lumen. The complex medical device according to claim 10, which is capable of operating in such a manner. A system for mechanically excising tissue and performing electrosurgical treatment of the tissue.
A motor drive unit and a blade that are selectively coupled to the motor drive unit, wherein the motor drive unit and the blade each have a fluid suction conduit in which the motor drive unit and the blade communicate with each other.
A motor drive unit controller that communicates with the motor drive unit,
A fluid suction controller configured to control the fluid flow rate through the motor drive unit and blade fluid suction conduit.
An RF generator that telecommunicationss with the active and return electrodes of the blade.
The blade comprises an outer sleeve having an inner sleeve disposed concentrically inside, the inner sleeve being coupled to the motor drive unit and moving relative to the outer sleeve to mechanically cut the tissue. Is configured to
The outer sleeve comprises an exposed conductive portion defining the return electrode and a ceramic spacer disposed through the lateral opening of the outer sleeve, wherein the ceramic spacer provides the active electrode. A system that is configured to be electrically separated from the outer sleeve. The fluid suction controller is communicably coupled to both the motor drive unit controller and the RF generator to control the flow rate with a first flow rate when the motor drive unit controller is in operation and the RF. 16. The system of claim 16, wherein the system is configured to control the flow rate at a second flow rate different from the first flow rate when the generator is in operation. 17. The system of claim 17, wherein the second flow rate defines a variable flow rate and the second flow rate is adjusted in response to a sensed parameter associated with the electrode circuit impedance of the blade. The suction controller is operably coupled to a position sensor associated with the angular orientation of the window through the inner sleeve with respect to the angular orientation of the window through the outer sleeve, and the second flow rate is said to the outer sleeve window. 17. The system of claim 17, which is at least partially controlled by controlling the angular orientation of the inner sleeve window. 17. The composite medical device of claim 17, wherein the outer sleeve comprises a window comprising an edge surface for mechanically cutting tissue and the return electrode comprises the edge surface.

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